ChemGenex Announces Granted U.S. Patent for Ceflatonin(R) Manufacturing.MELBOURNE, Australia & MENLO PARK, Calif. -- ChemGenex Pharmaceuticals (ASX ASX See: Australian Stock Exchange : CXS CXS Coherent X-Ray Scattering , NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CXSP) today announced that the United States Patent and Trademark Office The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent protection to inventors and businesses for their inventions, and trademark registration for product and intellectual property has granted a patent that protects the semisynthetic semisynthetic /semi·syn·thet·ic/ (-sin-thet´ik) produced by chemical manipulation of naturally occurring substances. sem·i·syn·thet·ic adj. 1. production of homoharringtonine (Ceflatonin([R])) and its analogs and the use of these compounds in a treatment of leukemia. The U.S. 7,169,774 B2 patent, entitled "Cephalotaxane Derivatives and Their Processes of Preparation and Purification" provides ChemGenex and its partner, Stragen Pharma, with a proprietary position until 2019 in the United States. "This is another very positive step in the Ceflatonin([R])development program that further consolidates our patent position," said Greg Collier, Ph.D., Chief Executive Officer and Managing Director. "In addition to the strong regulatory position obtained through patents and orphan drug status in major jurisdictions, the Ceflatonin([R])clinical development program is progressing very well. We now have 11 centers in the USA and Europe recruiting patients for our registration-directed trial of Ceflatonin([R]) in chronic myeloid leukemia (CML 1. CML - A query language. ["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986]. 2. CML - Concurrent ML. ) patients with the T315I mutation who have failed Gleevec([R]) therapy, and have a group of outstanding clinicians working with us. Following the granting of Fast Track status in November 2006, we are in ongoing discussion with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. concerning aspects of the development program and have the goal of completing enrollment in H2 2007." About Ceflatonin([R]) Ceflatonin([R]) (HHT) is a potent inducer inducer /in·duc·er/ (in-dldbomacs´er) a molecule that causes a cell or organism to accelerate synthesis of an enzyme or sequence of enzymes in response to a developmental signal. in·duc·er n. of apoptosis (programmed cell death pro·grammed cell death n. See apoptosis. programmed cell death proposed system of cell death, often including poly(ADP)-ribosylation, ensures that a cell will not survive if it is so badly damaged that its recovery would harm the ) in myeloid myeloid /my·eloid/ (mi´e-loid) 1. medullary; pertaining to, derived from, or resembling bone marrow or the spinal cord. 2. having the appearance of myelocytes, but not derived from bone marrow. cells and inhibits angiogenesis (blood vessel formation). In Phase 2 studies, Ceflatonin([R]) has demonstrated clinical activity in patients with CML, both as a single agent and in combination with other chemotherapeutic drugs. ChemGenex is developing Ceflatonin([R]) for the treatment of CML, and pilot studies are underway in myelodysplastic syndrome (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ) and in acute myeloid leukemia (AML AML - A Manufacturing Language ). Ceflatonin([R]) has a different mechanism of action than tyrosine kinase inhibitors (TKI's), and ongoing and proposed clinical studies seek to determine; 1. Efficacy in treatment of CML patients who have developed resistance to tyrosine kinase inhibitor (TKI) therapy due to development of the T315I Bcr-Abl kinase domain point mutation. The T315I Bcr-Abl mutation, which develops in some CML patients treated with TKI's, is associated with resistance to Gleevec([R]) and Sprycel([R]); 2. Efficacy in CML patients who have failed therapy with two tyrosine kinase inhibitors, e.g., Gleevec([R]) and Sprycel([R]) and; 3. Efficacy as combination therapy with Gleevec([R]), for the treatment of residual disease and to prolong Gleevec([R]) sensitivity in CML patients who have developed resistance to Gleevec([R]). Ceflatonin([R]) is not approved by the FDA as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications. Ceflatonin([R]) is a registered trademark of ChemGenex Pharmaceuticals Limited. Gleevec([R]) is a registered trademark of Novartis AG. Sprycel([R]) is a registered trademark of the Bristol-Myers Squibb Company. About ChemGenex Pharmaceuticals Limited (www.chemgenex.com) ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing therapeutics in the areas of oncology, diabetes, obesity, and depression. ChemGenex harnesses the power of genomics for target discovery and validation, and in clinical trials to develop more individualized therapeutic outcomes. ChemGenex's lead compound, Ceflatonin([R]), is currently in phase 2/3 clinical trials for chronic myeloid leukemia (CML) and Quinamed([R]) is in phase 2 clinical development for prostate, breast and ovarian cancers. The company has a significant portfolio of anti-cancer, diabetes, obesity and depression programs, several of which have been partnered with international pharmaceutical companies. ChemGenex currently trades on the Australian Stock Exchange Australian Stock Exchange (ASX) Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. under the symbol "CXS" and on NASDAQ under the symbol "CXSP". Safe Harbor Statement Certain statements made herein that use the words "estimate", "project", "intend", "expect", "believe", and similar expressions are intended to identify forward-looking statements within the meaning of the US Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements of the company to be materially different from those which may be expressed or implied by such statements, including, among others, risks or uncertainties associated with the development of the company's technology, the ability to successfully market products in the clinical pipeline, the ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated technologies, the ability to enter into additional collaborations and strategic alliances and expand current collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development, the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary technology, potential limitations on the company's technology, the market for the company's products, government regulation in Australia and the United States, changes in tax and other laws, changes in competition and the loss of key personnel. These statements are based on our management's current expectations and are subject to a number of uncertainties that could change the results described in the forward-looking statements. Investors should be aware that there are no assurances that results will not differ from those projected. |
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